(136 days)
The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.
This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.
The Revision Hedrocel® Patella is a modular porous backed patella consisting of a Hedrocel® Patellar Backing with titanium alloy suture ring and the current commercially available Continuum® Patella. The Revision Hedrocel® Patella provides the surgeon a method for augmenting defects in the patella typically encountered during revision surgery of the knee.
The provided text describes a 510(k) premarket notification for a medical device, the Implex Revision Hedrocel® Patella. The information focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, many of the requested details about acceptance criteria, device performance results, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies are not present in the provided document. This is common for 510(k) submissions, which often rely on similarities to previously cleared devices and existing performance data for those predicate devices.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of acceptance criteria and the reported device performance
This information is not explicitly stated in the document as a set of defined acceptance criteria with corresponding performance metrics from a new study. The submission relies on "similarities in design" and "performance testing submitted in K882322 and K971879, and Hedrocel® materials' data found in MAF #920" of predicate devices to conclude that the new device "will perform as intended."
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. No new performance study or test set data is described for the Implex Revision Hedrocel® Patella itself in this document. The submission relies on data from predicate devices.
- Data provenance: Not applicable/Not provided for a new test set for this device. The referenced predicate device data (K882322, K971879, MAF #920) would have their own provenance, but these details are not in the current document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No new performance study requiring expert adjudication to establish ground truth for a test set is described.
4. Adjudication method for the test set
Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical implant device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical implant device, not an algorithm.
7. The type of ground truth used
Not applicable/Not provided for this device's performance. The submission makes a "substantial equivalence" claim based on:
- "materials, design and articulating surface geometry" being "similar and/or identical" to predicate devices.
- Performance data of predicate devices (K882322 and K971879) and "Hedrocel® materials' data found in MAF #920."
The "ground truth" here is essentially the prior FDA clearance and established performance of the predicate devices and materials.
8. The sample size for the training set
Not applicable/Not provided. This device is not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable/Not provided.
{0}------------------------------------------------
3/15/99
K98 3835
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REVISION HEDROCEL® PATELLA
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | Robert Poggie, PhD or John Schalago, RAC |
| Phone Number: | (201) 818-1600 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | October 29, 1998 |
| Device Trade Name: | Continuum Patella-Revision Hedrocel® |
| Device CommonName: | Prosthesis, Patellar |
| Classification Name: | Knee Joint Patellofemorotibial Polymer/Metal/PolymerSemi-Constrained Cemented Prosthesis |
| Predicate Device(s): | Patellar Component of Continuum Knee System(CKS), Implex Corp. (K882322); Continuum PorousPatella, Implex Corp. (K971879), Konstruct Patellar,Biomet, Inc. (K960856) |
| Device Description: | The Revision Hedrocel® Patella is a modular porousbacked patella consisting of a Hedrocel® PatellarBacking with titanium alloy suture ring and the currentcommercially available Continuum® Patella. TheRevision Hedrocel® Patella provides the surgeon amethod for augmenting defects in the patella typicallyencountered during revision surgery of the knee. |
| Intended Use: | The Implex Revision Hedrocel® Patella is intendedas the patellar component of the Continuum KneeSystem whose indications for use include: 1)noninflamatory degenerative joint disease includingosteoarthritis or traumatic arthritis, 2) rheumatoidarthritis, 3) correction of functional deformity, 4)revision procedures where other treatments ordevices have failed, 5) treatment of fractures that areunmanageable using other techniques, and 6) comp- |
| Intended Use(continued) | This device is intended for use with bone cement andsupplemental fixation by means of suture attachment.Supplemental suture attachment may be used incases where additional device support can beobtained. |
| DeviceTechnologicalCharacteristics andComparison toPredicate Device(s): | The materials, design and articulating surfacegeometry of the Revision Hedrocel® Patella is similarand/or identical to the claimed predicate devices fromImplex Corp. and Biomet Inc. |
| Performance Data: | Based on similarities in design of the RevisionHedrocel® Patella and the predicate devices, theperformance testing submitted in K882322 andK971879, and Hedrocel® materials' data found inMAF #920, supports the conclusion that the devicewill perform as intended. |
| Conclusion: | The Revision Hedrocel® Patella is substantiallyequivalent to the predicate devices in terms ofintended use, safety, and effectiveness. |
{1}------------------------------------------------
。
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
K983835 Re: Implex Revision Hedrocel® Patella Trade Name: Regulatory Class: II Product Code: JWH Dated: January 21, 1999 Received: January 22, 1999
Dear Dr. Poggie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Robert A. Poggie, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known):
Device Name:
Implex Revision Hedrocel® Patella
Indications For Use:
The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.
This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Pcolleto
(Division Sign-Off)
Division of General Restorative Devices K98382
510(k) Number
Prescription Use (Per 21 CFR 801.109) OR ...
Over-The-Counter Use
μs
(Optional Format 1-2-96)
(Division Sign-Off)
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.